​​VP, CMC

​ Location: San Diego, USA

We are seeking a motivated and passionate leader that has a great personality and feels comfortable working within a dynamic company. We are seeking a candidate that enjoys their work and likes to work with creative and funny people. Our client is seeking a Vice President of Chemistry, Manufacturing, and Controls to provide the vision, direction, and strategy to lead and expand the company’s proprietary programs through preclinical, clinical, and commercial stages. In particular, the VP of CMC will oversee the company’s entire outsourced manufacturing effort and the company’s programs. For this position, we are looking for a seasoned biotech executive with an outstanding record of accomplishment in R&D manufacturing of biologics, quality, supply chain management, and logistics and with experience in the global submission and maintenance of CMC sections of regulatory filings.

This position oversees, manages, and provides development opportunities for technical leaders in all areas of pharmaceutical development, manufacturing, planning, procurement, logistics, production control, and quality control functional managers. You will also be accountable for implementing the executive strategy by defining deliverables in the context of the corporate plan for each functional area and then measuring the results against the goals.

This leader will be responsible for assuring a reliable preclinical, clinical and future supply of safe, high-quality drug products and will lead the manufacturing strategies and address any capacity issues. This position will be responsible for directing and managing the company’s external contract research and manufacturing operations and ensure appropriate processes are in place to support clinical manufacturing. Work with regulatory affairs colleagues to help manage and monitor the preparation, assembly, and filing of CMC regulatory submissions to support new product approvals and existing brands, including interactions between the company and health authority representatives to facilitate IND, BLA, and other submissions.

Salary: On application